FDA recall Z-0029-2026

Product

NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

Reason for recall

The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

Distribution

Domestic: TN;

Key facts

Status

Ongoing

Initiation date

2025-09-09

Report date

2025-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sittingbourne, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0029-2026